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Updated: Jan 14, 2026
MRI-guided dmPFC-rTMS as a Treatment for Treatment-resistant Major Depressive Disorder
Published on: August 11, 2015
Active versus sham transcranial pulsed electromagnetic field headband treatment for major depression: protocol for a
Nana Brandborg Sørensen1,2, Ulrik Haahr3, Malina Ploug Larsen4
1Copenhagen Affective Disorder Research Center (CADIC), Copenhagen Psychiatric Center, Frederiksberg Hospital, Copenhagen, Denmark nana.brandborg.soerensen@regionh.dk.
Introduction:
A substantial number of patients with major depressive disorder experience non-remission despite treatment with psychotherapy and several antidepressant drugs. This has increased the interest in new treatment strategies, including non-invasive brain stimulation methods. This randomised controlled trial examines a new treatment method using transcranial-pulsed electromagnetic fields (T-PEMF) delivered via a MoodHeadBand (MHB). The main study objective is to examine the antidepressant effect of T-PEMF on moderate to severe depression.
Methods And Analysis:
A double-blinded, randomised (1:1), sham-controlled trial with 96 participants diagnosed with moderate to severe depression without psychotic symptoms, recruited from Psychiatric Center Copenhagen. Participants receive daily 30 min at-home T-PEMF or sham treatment for 8 weeks with the MHB. Depressive symptomatology is examined using the Inventory of Depressive Symptomatology (Self-Report) (primary outcome) and Hamilton-D-17 Items Rating Scale at baseline and treatment completion. Cognitive functions are examined using a battery of emotion-laden and non-emotion-laden tests at baseline, after 1 week and at treatment completion. The participants fill out the Quick Inventory of Depressive Symptomatology (Self-Report) and sleep logs weekly. Summary statistics, generalised linear models, proc mixed models, mixed model repeated measures and Kaplan-Meier analysis will be applied as appropriate to analyse data on depressive symptoms, cognition and sleep.
Ethics And Dissemination:
The Danish Medicines Agency (CIV-23-01-041987) and the Medical Research Ethics Committee (2215332) have approved the trial. The project concurs with the EU directive for medical devices 2017/745 of 5 April 2017 and the ISO 14155 standard. Participants give written informed consent before any trial-related activities. Results will be published in peer-reviewed journals and presented at relevant conferences.
Trial Registration Number:
NCT06005103.
